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Rx Item-Tasigna 150Mg Cap 4X28 By ASD Healthcare

NDC 00078-0592-87 UPC/GTIN No.3-00780-59287-1 Mfg.Part No.36168BRAND: TASIGNA  NDC: 00078-0592-87,78059287 UPC: 3-00780-59287-1,300780592871 ASD Specialty Healthcare-Special OrderOnly Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scopWant to do Research on this Med or need a large quantity? Email Details with quantity required to:sales@AmericanPharmaWholesale.comVisit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.

Rx Item-Tasigna 150Mg Cap 4X28 By ASD Healthcare

$18895.37$16818.69

Item No.: RX101311 NDC No.78059287 UPC No.:300780592871 NDC No.00078-0592-87 UPC/GTIN No.3-00780-59287-1 MPN 36168 Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,ResearchCo.,Uni.,VA,Vet & Wholesalers in scope of practice can order this RX item. Rx Item No.Rx101311 Tasigna 150mg Cap 4X28 by ASD Healthcare Item No.3101311 NDC No.00078059287 UPC No.300780592871 Other Name Tasigna Therapeutic C

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TASIGNA- nilotinib capsule
Novartis Pharmaceuticals Corporation

WARNING: QT PROLONGATION AND SUDDEN DEATHS

Tasigna prolongs the QT interval. Prior to Tasigna administration and periodically, monitor for hypokalemia or hypomagnesemia and correct deficiencies (5.2). Obtain ECGs to monitor the QTc at baseline, seven days after initiation, and periodically thereafter, and following any dose adjustments (5.2, 5.3, 5. 7 , 5. 15 ).


Sudden deaths have been reported in patients receiving nilotinib (5.3). Do not administer Tasigna to patients with hypokalemia, hypomagnesemia, or long QT syndrome (4, 5.2).
Avoid use of concomitant drugs known to prolong the QT interval and strong CYP3A4 inhibitors (5. 8 ).
A void food 2 hours before and 1 hour after taking the dose (5. 9 ).
1 INDICATIONS AND USAGE

1.1 Newly Diagnosed Ph+ CML-CP
Tasigna (nilotinib) is indicated for the treatment of adult patients with newly diagnosed Philadelphia chromosome positive chronic myeloid leukemia (Ph+ CML) in chronic phase. The effectiveness of Tasigna is based on major molecular response and cytogenetic response rates [see Clinical Studies (14.1)].

1.2 Resistant or Intolerant Ph+ CML-CP and CML-AP
Tasigna is indicated for the treatment of chronic phase and accelerated phase Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) in adult patients resistant or intolerant to prior therapy that included imatinib. The effectiveness of Tasigna is based on hematologic and cytogenetic response rates [see Clinical Studies (14.2)].

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosing
Tasigna should be taken twice daily at approximately 12-hour intervals and must be taken on an empty stomach. No food should be consumed for at least 2 hours before the dose is taken and for at least 1 hour after the dose is taken. Advise patients to swallow the capsules whole with water [see Boxed Warning, Warnings and Precautions (5.9), Clinical Pharmacology (12.3)].

For patients who are unable to swallow capsules, the contents of each capsule may be dispersed in 1 teaspoon of applesauce (pur�ed apple). The mixture should be taken immediately (within 15 minutes) and should not be stored for future use [see Clinical Pharmacology (12.3)].

Tasigna may be given in combination with hematopoietic growth factors such as erythropoietin or G-CSF if clinically indicated. Tasigna may be given with hydroxyurea or anagrelide if clinically indicated.

Newly Diagnosed Ph+ CML-CP

The recommended dose of Tasigna is 300 mg orally twice daily [see Clinical Pharmacology (12.3)].

Resistant or Intolerant Ph+ CML-CP and CML-AP

The recommended dose of Tasigna (nilotinib) is 400 mg orally twice daily [see Clinical Pharmacology (12.3)].
DOSAGE FORMS AND STRENGTHS

150 mg red opaque hard gelatin capsules with black axial imprint "NVR/BCR."

200 mg light-yellow opaque hard gelatin capsules with a red axial imprint "NVR/TKI."

4 CONTRAINDICATIONS

Do not use in patients with hypokalemia, hypomagnesemia, or long QT syndrome [see Boxed Warning].
DESCRIPTION

Tasigna (nilotinib) belongs to a pharmacologic class of drugs known as kinase inhibitors.

Nilotinib drug substance, a monohydrate monohydrochloride, is a white to slightly yellowish to slightly greenish yellow powder with the anhydrous molecular formula and weight, respectively, of C28 H22 F3 N7 O�HCl � H2 O and 584. The solubility of nilotinib in aqueous solutions decreases with increasing pH. Nilotinib is not optically active. The pKa 1 was determined to be 2.1; pKa 2 was estimated to be 5.4.

The chemical name of nilotinib is 4-methyl-N-[3-(4-methyl-1H-imidazol-1-yl)-5-(trifluoromethyl)phenyl]-3-[[4-(3-pyridinyl)-2-pyrimidinyl]amino]-benzamide, monohydrochloride.
Tasigna (nilotinib) capsules, for oral use, contain 150 mg or 200 mg nilotinib base, anhydrous (as hydrochloride, monohydrate) with the following inactive ingredients: colloidal silicon dioxide, crospovidone, lactose monohydrate, magnesium stearate and poloxamer 188. The capsules contain gelatin, iron oxide (red), iron oxide (yellow), iron oxide (black), and titanium dioxide.

12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action
Nilotinib is an inhibitor of the BCR-ABL kinase. Nilotinib binds to and stabilizes the inactive conformation of the kinase domain of ABL protein. In vitro, nilotinib inhibited BCR-ABL mediated proliferation of murine leukemic cell lines and human cell lines derived from patients with Ph+ CML. Under the conditions of the assays, nilotinib was able to overcome imatinib resistance resulting from BCR-ABL kinase mutations, in 32 out of 33 mutations tested. In vivo, nilotinib reduced the tumor size in a murine BCR-ABL xenograft model. Nilotinib inhibited the autophosphorylation of the following kinases at IC50 values as indicated: BCR-ABL (20 to 60 nM), PDGFR (69 nM), c-KIT (210 nM), CSF-1R (125 to 250 nM), and DDR1 (3.7 nM).

NDC 00078-0592-87 UPC/GTIN No.3-00780-59287-1 Mfg.Part No.36168
RX ITEM-Tasigna 150Mg Cap 4X28 By ASD He
NDC 00078-0592-87 UPC/GTIN No.3-00780-59287-1 Mfg.Part No.36168

BRAND: TASIGNA  NDC: 00078-0592-87,78059287 UPC: 3-00780-59287-1,300780592871 ASD Specialty Healthcare-Special Order
Tasigna 150Mg Cap 4X28 By ASD Healthcare
BRAND: TASIGNA NDC: 00078-0592-87,78059287 UPC: 3-00780-59287-1,300780592871 ASD Specialty Healthcare-Special Order

Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop
NILOTINIB HCL ORAL CAPSUL
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Visit AmericanPharmaWholesale.com for over 100,000 items of Health & Beauty at Retail@Wholesale prices.